Johnson & Johnson (J&J) announced yesterday that it is voluntarily withdrawing its laparoscopic power morcellators on a worldwide basis as the controversy escalates over the risk of the devices spreading unsuspected malignant tumors.
Ethicon, the J&J business unit that markets the morcellators, said in a statement emailed to Medscape Medical News that the company is withdrawing the devices because "the risk- benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroid tumors remains uncertain."
The move represents a stronger version of a company decision announced in late April to suspend worldwide sales of its power morcellators, which shred tissue into smaller pieces. The decision came after the US Food and Drug Administration (FDA) warned on April 17 that the devices may disperse occult cancer in the course of fibroid removal.
A regulatory crackdown appeared imminent earlier this month when the majority of members of an FDA advisory panel endorsed putting a boxed warning on device labels about the risk of spreading occult cancer, as well as other adverse events. At its meeting, the panel heard conflicting testimony from physicians about the pros and cons of laparoscopic power morcellation. One physician went so far as to call it "bad medicine," while others said the surgical technique should be improved but not abandoned, given the greater risks posed with open surgery.
In its statement today, Ethicon said that withdrawing its morcellators is not the same as recalling them, which implies a performance problem. "The product performs as intended," the company said.
Essentially, the J&J business unit is waiting until the smoke clears on morcellation and its cancer risk before taking its next step.
"Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action...until further medical guidelines are established and/or new technologies are developed to mitigate the risk," the company said.
Cite this: J&J Withdraws Morcellators Due to Cancer 'Uncertainty' - Medscape - Jul 31, 2014.